Wednesday, December 2, 2015

Today the Federal Circuit issued an order (available here) denying
en banc rehearing of Ariosa v. Sequenom,
an important patent eligibility decisions discussed in earlier posts.I filed a brief on behalf of the
Biotechnology Industry Organization (BIO) and Pharmaceutical Research and
Manufacturers of America (PhRMA) arguing in favor of en banc rehearing, and
discussing the negative implications of the decision for patenting in
biotechnology, particularly as related to diagnostics and personalized medicine.
The decision to deny rehearing was
accompanied by two concurring and one dissenting opinions filed by a total of
four judges (Lourie and Moore, Dyk, and Newman), which provide some very
interesting insight into their views on the current state of patent eligibility
jurisprudence, particularly as it relates to the life sciences.

There was some substantial overlap in the opinions of all
four judges.For example, they all
appeared to agree that the decision invalidating Sequenom’s method was both
ill-advised as a matter of policy and not compelled by the language of the
patent statute.All of the judges seemed
to recognize that Ariosa’s interpretation
and application of the Mayo framework
threatened the availability of effective patent protection for a broad swath of
biotechnological innovation, particularly in the area of diagnostics.Lourie and Moore, for example, found “some
truth” in concerns raised by Sequenom and their amici “that a crisis of patent
law and medical innovation may be upon us,” and that a broad range of claims
appear to be in serious jeopardy, particularly diagnostic claims.

The judges recognized that the claims might raises concerns
regarding overbreadth and/or indefiniteness, but suggested more measured
approaches to address these concerns rather than the blunt instrument of the
Supreme Court’s new patent eligibility jurisprudence.Lourie and Moore suggested that “the finer
filter of Section 112 [i.e., the enablement and definiteness requirement] might
be better suited to treating these [concerns] as questions of patentability,
rather than reviewing them under the less-defined eligibility rules.” In
contrast, Judge Dyk opined that these other statutory requirements of
patentability might not be entirely up to the task, but instead proposed a novel
alternative approach to patent eligibility analysis that would have likely
salvage some patent protection for a company like Sequenom, albeit at the cost
of substantially narrower claim scope.His suggested approach is discussed in more detail below.

The concurrence by Lourie and Moore found that while the
blood fractionation and DNA analysis steps recited in the claims are
individually well known, “the innovative aspect of the claims appears to be the
improvement in the method of determining fetal genetic characteristics []
consisting of use of the non-cellular fraction of fetal DNA obtained from
maternal blood sample.”The result is a
novel, innovative and practical method of diagnosis that constitute a
substantial improvement over the highly intrusive means use prior to the
invention.

Lourie and Moore went on to find that the claims would not
preempt the asserted natural phenomenon, since there exist “other uses for
cffDNA and other methods of prenatal diagnostic testing using cffDNA that do not
involve the steps recited in the various claims,” and that this “fact should
sufficiently address the concern of improperly tying up future use of natural
phenomena and laws.”In other words, these
judges appear to support the notion that a claim only raises patent ineligibility
concerns if it preempts all applications of a natural phenomenon.This is in stark contrast to the approach of
the panel that decided Ariosa - they treated
the question of preemption as essentially irrelevant to the determination of
patent eligibility.

Dyk’s concurring opinion largely tracked Lourie and Moore,
agreeing that the language of Mayo,
while unfortunate, compelled the panel decision in Ariosa.But Dyk goes on to
suggest that in assessing patent eligibility courts should distinguish between
a patent eligible concept that is well known and long-standing at the time of
invention as opposed to one that is newly discovered.In his view:

Mayo did not fully
take into account the fact that an inventive concept can come not just from
creative, unconventional application of a natural law, but also from the
creativity and novelty of the discovery of law itself.This is especially true in the life sciences,
or development of useful new diagnostic and therapeutic methods is driven by
investigation of complex biological systems.I worry that method claims that apply newly discovered natural laws and
phenomena in some conventional ways are screened out by the Mayo test.In this regard I
think that Mayo may not be entirely
consistent with the Supreme Court’s decision in Myriad.

I think Judge Dyk raises a very interesting and insightful
point regarding Myriad.In that case, the Supreme Court found that
the genetic sequence of the BRCA genes was a natural phenomenon, but that the
corresponding cDNA sequences were nonetheless patent eligible, in spite of the
fact that nothing could be more routine and conventional than to synthesize
cDNA based on the discovery of a naturally occurring gene. Judge Dyk inferred that Myriad “recognize[d] that an inventive concept can sometimes come
from discovery of an unknown natural phenomenon, not just from unconventional
application of the phenomenon.”He went
on to propose a refinement of the Supreme Court’s test for patent eligibility,
whereby “the novelty of the discovery [of a natural phenomenon] should be
enough to supply the necessary inventive concept.”

Significantly, under Dyk’s proposed approach, an inventor
would only be able to claim applications of a newly discovered natural phenomenon
that had been “actually reduced practice, not merely ‘constructively” reduced
to practice by filing of a patent application replete with prophetic examples.”According to Dyk, the resulting claims would
be narrow in scope and “would allow the inventor to enjoy an exclusive right to
what he himself has invented and put into practice, but not to prevent new
applications of the natural law by others.”In other words, the narrow scope of the claims would obviate the
preemption concerns underlying the patent eligibility doctrine.

Dyk’s concurrence concludes by suggesting that:

A future case is likely to present a patent claim where the
inventive concept resides the newly discovered law of nature or natural
phenomenon, but the claims narrowly drawn and actually reduced practice.That case will, I hope, provide the Supreme
Court with an opportunity to revisit the
Mayo/Alice framework in this one limited aspect.

The third opinion was a dissent by Judge Newman.Not surprisingly, she agreed with the other
judges that the decision below was wrongly decided, but she did not “share
their view that this incorrect decision is required by Supreme Court precedent.”She found that the facts of Ariosa diverge significantly from those
in Mayo and Myriad, and that the patent eligibility of Sequenom’s claims could
be upheld without contravening Supreme Court precedent.

7 comments:

That's a quite thorny problem between the professionals and patients in drug discovery. On the pre-condition that docs and researchers won't make use of such material gained from patients for commercial or bad aims, there won't be any problems. But regulation and laws should emphasize the importance of normal application of such material.

About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.